Delimitation of live animals as medicinal products
In accordance with Section 1 (3b) of the Austrian Medicines Act, Federal Law Gazette No. 185/1983, as amended, the following official demarcation has been made in response to questions submitted to the Federal Office for Safety in Health Care with regard to the demarcation of live animals as medicinal products.
Basic information on the definition of medicinal products
According to Directive 2004/27/EC, all substances or combinations of substances are medicinal products, either insofar as they are intended to be used as agents having properties for treating or preventing human disease (definition "according to presentation") or which may be used in or on the human body or administered to a human being either to restore, correct or influence human physiological functions by a pharmacological, immunological or metabolic action or to make a medical diagnosis (definition "according to function").
In addition, as the ECJ has also consistently held, a product is thus a medicinal product under Community law if it falls within one of these two definitions, i.e. either by presentation or by function.
The fact that live animals can in principle also be subject to the Medicinal Products Act, since they meet the substance definition of Section 1(4)(3) of the Medicinal Products Act, provided that the requirements for classification are met, namely according to function or presentation, can also be inferred from Section 7(6d) of the Medicinal Products Act, which provides for an exemption from the licensing requirement for live animals.
Animals used in "practice
According to the knowledge of the Federal Office for Safety in Health Care and as can be seen from the explanations to § 7 para. 6d Medicinal Products Act, at least three "animals" are used in the "practice". These are fly maggots, leeches and so-called nibbling fish.
Classification of "nibble fish" - fish as medicinal products
Fish of the genus Garra rufa (red sucker mullet) are used externally in skin diseases such as psoriasis vulgaris or atopic dermatitis for ichthyotherapy. They are also called kangal fish due to the presence of a population in the Kangal region of Turkey. The fish nibble off the skin scales and eat them ("nibbling fish").
In order to classify nibble fish as medicinal products, it is necessary to assess according to function on the one hand and presentation on the other.
Assessment according to function
Functional medicinal products are defined as any substance or combination of substances that may be used in or on the human body or administered to a human being for the purpose of either restoring, correcting or modifying human physiological functions by a pharmacological, immunological or metabolic action, or for the purpose of making a medical diagnosis.According to the files available to the Federal Office for Safety in Health Care, the application of kangal fish is only expected to have a mechanical effect by nibbling off skin scales. A secretion of medicinally active secretions has not been proven so far.
Due to the lack of pharmacological, metabolic or immunological effect, these are therefore not currently classified as functional drugs.
Post-Presentation Assessment
Presentational drugs are defined as agents intended to cure or prevent disease. Provided that nibble fish are advertised as a remedy for use in patients with skin diseases, they can be classified as presentation medicinal products.
Leechesand fly larvae have been classified as medicinal products to dateLeechesare used for bloodletting as well as in plastic surgery, and have also been shown to produce symptomatic improvement in studies of their use in osteoarthritis.
The leech's cheek secretion contains the anticoagulant hirudin as well as anti-inflammatory substances. Hirudin is a direct thrombin inhibitor, which is also contained in Austrian medicinal preparations for local use in superficial phlebitis, inflammatory infiltrates, hematomas, and the like. Due to the content of pharmacologically active substances in the cheek secretion, which enter the human body, the medicinal property is given.
Maggots are used for wound healing in chronic wounds. Maggots also release substances during application. These have proteolytic and antibacterial effects. They may also stimulate wound healing.
Due to the release of these pharmacologically active substances, a medicinal property is given.
Why live animals cannot be medical devices
In connection with the classification of live animals, the question repeatedly arises as to whether they cannot also be considered medical devices due to their intended purpose.
This is clearly regulated by law in Section 4 (1) (5) of the Medical Devices Act. This provision states that the Medical Devices Act does not apply to transplants, tissues or cells of animal origin, unless a medical device is manufactured using killed animal tissue or killed products obtained from animal tissue, or unless it is an in vitro diagnostic device.
Since live animals are probably unquestionably not killed animal tissue, they cannot be subsumed under the Medical Devices Act and thus live animals are not considered medical devices.
Summary
In summary, it can be stated that live animals, insofar as they can be classified as functional medicinal products, are considered medicinal products within the meaning of the Medicinal Products Act. As explained, this includes leeches and fly larvae in particular. In this respect, however, there are differences to nibbling fish, as these cannot be delineated as functional medicinal products.
It would only be conceivable to classify them as presentation medicinal products on the basis of their intended purpose, insofar as they are advertised for use in skin diseases. If necessary, a corresponding change in the advertising would have to be made so that the prerequisites of the presentation medicinal product are no longer fulfilled.
This statement serves as a basic consideration of the delimitation of live animals as medicinal products. However, a concrete classification can only be made in individual cases by the Federal Office for Safety in Health Care.
Further inquiries:
Mag. Thomas Reichhart
E-mail: thomas.reichhart@ages.at
